HOUSTON, Nov. 10,
2019 /PRNewswire/ — Bryn Pharma, LLC (“Bryn” or the “Company”), a privately held
pharmaceutical company dedicated to finding a better way for patients and
caregivers to treat anaphylaxis, announced that the results of two studies
supporting the potential benefits of its BRYN-NDS1C product candidate, Bi-dose
Epinephrine Nasal Spray, were presented today at the Annual Scientific Meeting of
the American College of Asthma, Allergy and Immunology (ACAAI) in Houston,
TX.

Effect of Histamine-Induced Nasal Congestion
on IN Epinephrine Absorption

Results from a study
evaluating the impact of nasal congestion on epinephrine pharmacokinetics (PK)
and heart rate after intranasal epinephrine administration demonstrated that
histamine-induced nasal congestion, a common symptom seen in patients
experiencing an anaphylactic event, increased the absorption of intranasal
epinephrine and led to a more rapidly increased heart rate.

“Since histamine
is released during the immunologic cascade of events associated with an
anaphylactic reaction which leads to nasal congestion, a key focus of our
pre-clinical program was to demonstrate that administering epinephrine intranasally
to a congested patient doesn’t interfere with the delivery of the drug,”
said David Dworaczyk, Ph.D., CEO of Bryn Pharma. “The results
presented today demonstrated that epinephrine was absorbed more rapidly in this
pre-clinical congestion model. We are looking forward to completing our
clinical program shortly.”

In a second
presentation at the ACAAI meeting today, researchers presented results from a
multicenter, randomized preference study which demonstrated that healthcare
professionals had a statistically significant preference for BRYN-NDS1C over
the EpiPen® Auto-Injector for all study metrics,
including ease of use, portability and safety. The researchers also concluded,
considering that the most common cause of death from food allergies is delayed
epinephrine administration, prescription and use of BRYN-NDS1C might decrease
the incidence of anaphylactic deaths. These findings are consistent with the
results of a study presented at the American Academy of Pediatrics Conference
last month demonstrating patient preference for the product candidate,
BRYN-NDS1C, versus EpiPen® Auto-Injector. HCP preference for
BRYN-NDS1C was evaluated across a series of key parameters including:

Dworaczyk added,
“We are also pleased to share results from our follow-on, healthcare
professional preference study with those at the forefront of allergy care. This
study, which aligns with our patient preference data, suggests that the use of
Bryn’s Bi-dose Epinephrine Nasal Spray instead of the Epinephrine Auto-Injector
for the treatment of anaphylaxis may increase patient adherence, decrease the
time to treat symptoms and potentially reduce hospitalization and anaphylactic
deaths.”

About the StudiesNasal Congestion StudyThree dogs
participated in a nasal congestion pilot study to assess the effects of INH on
nasal congestion response in dogs compared with intranasal saline
administration. Anesthetized dogs received a single dose of 5 percent
histamine. Intranasal histamine increased nasal pressure at 60, 80 and 100
minutes after dose.

After the pilot study,
the effects of intranasal epinephrine on epinephrine pharmacokinetics and heart
rate were evaluated in two groups (histamine versus saline) consisting of six
dogs each. Anesthetized dogs received either a single intranasal dose of 5
percent histamine or nebulized saline followed by a single intranasal
epinephrine dose (4 mg/100 µL). Changes in nasal pressure were measured at
varying intervals from 0 to 130 minutes. During this study, no animals were
injured, and all dogs were adopted into foster homes once the study was
completed.

Pharmacokinetics

Blood sampling was
performed before dosing and at set time points up to 130 minutes.

Histamine
administration produced a higher peak epinephrine concentration (Cmax) of 3.5ng/mL versus 1.7ng/mL in the saline group following IN
epinephrine (p=0.06)

Healthcare
Professional Preference StudyIn a multi-center,
randomized crossover preference study of Bi-dose Epinephrine Nasal Spray versus
EAI, preference was evaluated in an eight-item, forced-choice questionnaire
that was developed based on differences between the Bi-dose Epinephrine Nasal
Spray and EAI for epinephrine administration. Two user groups participated in
the preference study including 56 patients with severe allergies (results from
the patient preference study were previously presented) and 56 healthcare
professionals who treat patients with severe allergies (15 primary care
physicians, 15 allergy/immunology physicians, 16 primary care nurses/trainers,
and 10 allergy/immunology nurses/trainers). Participants attended a one-on-one
session to learn how to use both devices. After using both training devices,
participants completed an eight-item questionnaire.

The assessment of
preference was based on the following metrics: ease of patient training, ease
of use, portability, safety, comfort, size and emergency. For all metrics
evaluated, the survey results indicated a statistically significant preference
for the Bi-dose Epinephrine Nasal Spray over the EAI.

About the Clinical
Development Program for BRYN-NDS1CBryn’s Bi-dose
Epinephrine Nasal Spray (BRYN-NDS1C) is a single, portable, needle-free device
capable of delivering two therapeutic doses of epinephrine, replacing the need
to carry two epinephrine auto-injectors. In early 2019, the U.S. Food and Drug
Administration (FDA) granted Fast Track Designation to BRYN-NDS1C. In October
2019 the Company completed dosing in the pivotal human trial designed to
support U.S. approval to market the product candidate. BRYN-NDS1C is not
currently approved for sale by the FDA or any international regulatory
authority.

About AnaphylaxisAnaphylaxis is a
serious, life-threatening allergic reaction. The most common anaphylactic reactions
are to foods, insect stings, medication and latex.1 A major difference between anaphylaxis and other allergic
reactions is that anaphylaxis typically involves more than one system of the
body.2 Anaphylaxis requires immediate medical
treatment, driving approximately 100,000 emergency room visits in the U.S. each
year.1,3 Because 30 percent of patients who
develop anaphylaxis will require a second dose of epinephrine to control
symptoms, practice parameters recommend that physicians provide patients with
two auto-injectors.4 If not treated properly, anaphylaxis can
be fatal.2 However, studies have shown that the majority
of people at risk for anaphylaxis often do not carry two Epinephrine
Auto-Injectors due in part to size and cost of the products, putting patients
at greater risk of severe complications during an allergic reaction.

About Bryn PharmaBryn Pharma, founded
in 2016, is a privately held pharmaceutical company founded by patients for
patients. Bryn is focused on positively disrupting the existing market for
epinephrine auto-injectors by delivering an accessible, easy-to-use alternative
that better meets the needs of patients. Bryn Pharma seeks to provide this
growing population at risk for anaphylaxis with A Better Way to
be prepared for a life-threatening allergic reaction. For more information
visit www.brynpharma.com.

EpiPen is a registered
trademark of Mylan Inc.

Forward-Looking
StatementsStatements made in
this press release that look forward in time or that express beliefs,
expectations or hopes regarding future occurrences or anticipated outcomes or
benefits are forward-looking statements. A number of risks and uncertainties,
such as risks related to product development and commercialization efforts,
results of clinical trials, ultimate clinical outcomes and benefit of the
Company’s products to patients, market and physician acceptance of the
Company’s products, intellectual property protection and competitive product offerings,
could cause actual events to differ from the expectations indicated in these
forward-looking statements. You are cautioned not to put any undue reliance on
any forward-looking statement. This press release is neither an offer to sell
nor a solicitation of an offer to purchase any particular securities. Any such
offer or solicitation will be made only pursuant to definitive legal agreements
prepared specifically for such purpose. An investment in the Company’s
securities entails significant risks and is suitable only for sophisticated
investors who can afford a loss of their entire investment; no assurance can be
given that investment objectives will be achieved. In considering the
performance information contained herein, you should bear in mind that past
performance is not necessarily indicative of future results; there can be no
assurance that the Company will achieve comparable results or that any
projected returns will be met. The Company does not assume any obligation to
publicly update or revise any forward-looking statements, whether as a result
of new information, future events, or otherwise.